Baum Hedlund Aristei & Goldman changed its name to Wisner Baum in January 2023.

Leading Zantac Cancer Lawyers Over $4 Billion in Verdicts & Settlements

Reasons to Choose Us:

  • Our Attorneys Are Recognized as Top Plaintiff Lawyers
  • Strong Reputation for Successfully Litigating Against Big Pharma
  • Co-Lead Counsel in First Zantac Trial (July 2023)
  • $2B Verdict, 2nd Largest Personal Injury Verdict in USA in 2019 (Monsanto Roundup cancer lawsuit)

Zantac Lawsuit

Wisner Baum Co-Leads First Zantac Trial in July 2023

Zantac Lawsuit Update: March 2023

  • People who developed cancer after taking Zantac (generic: ranitidine) may choose to file a Zantac lawsuit against the drug manufacturers to recover financial compensation for past, present, and future medical bills, lost wages, and other damages.
  • Check to see if you are eligible to pursue a Zantac lawsuit by filling out this confidential case evaluation form.
  • Independent laboratory testing found that one ranitidine 150 mg tablet produced 304,500 nanograms (ng) of a cancer-causing substance called N-Nitrosodimethylamine (NDMA), an amount that greatly exceeds the U.S. Food and Drug Administration’s (FDA) daily acceptable intake limit of 96 ng.
  • Zantac lawsuits began after the FDA confirmed that ranitidine contains NDMA. On April 1, 2020, the FDA requested a market withdrawal for Zantac ranitidine drugs, stating that NDMA in some ranitidine medications “increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels…”
  • The FDA, the Environmental Protection Agency (EPA), and the World Health Organization (WHO) all classify NDMA as a cancer-causing substance.
  • Several manufacturers, including Sanofi and GlaxoSmithKline (GSK) have issued voluntary Zantac recall announcements, citing safety concerns.
  • In December of 2022, the judge overseeing the federal Zantac multidistrict litigation (MDL) in Florida issued an order dismissing cases in federal court. The order does not affect cases in state courts. At Wisner Baum, we do not have a single case in the MDL, meaning our clients’ quest for justice continues.

  • Jury selection in the first Zantac trial is scheduled to begin on July 24, 2023 in Oakland, California. Wisner Baum’s lead trial attorney R. Brent Wisner will serve as co-lead trial counsel. The case is James Goetz v. GlaxoSmithKline, LLC, Superior Court of California, Alameda County. For the latest update on Zantac cases throughout the country, visit our Zantac Trial Schedule page.

Which Cancers Qualify for the Zantac Lawsuit?

Our law firm is currently accepting Zantac cancer cases on behalf of people who took the drug for at least one year and developed the following cancers:

  • Bladder cancer
  • Esophageal cancer
  • Gastric cancer / stomach cancer
  • Liver cancer
  • Pancreatic cancer
  • Prostate cancer
  • Breast cancer
  • Lung cancer
  • Colon cancer

Those who are eligible and meet certain requirements must submit their claim within a time limit called the statute of limitations. We advise anyone who is considering a Zantac lawsuit to speak with an attorney as soon as possible to ensure that they are not time-barred from pursuing a claim.

Please note that Zantac lawsuit eligibility may change at any time in accordance with court orders.

Zantac Lawyers with Billions in Verdicts and Settlements

Class action lawyers from the national law firm of Wisner Baum represent thousands of people from across the country with personal injury and wrongful death claims against the makers of Zantac:

  • Boehringer Ingelheim Pharmaceuticals, Inc., a subsidiary of Boehringer Ingelheim Corporation
  • Sanofi US Services Inc., a wholly owned subsidiary of Sanofi S.A.
  • Pfizer, Inc.
  • GlaxoSmithKline, LLC

How We Can Help With Your Zantac Lawsuit

The trial-ready team of attorneys at Wisner Baum intend to hold the makers of Zantac accountable for allegedly concealing the ranitidine cancer link. With more than $4 billion in verdicts and settlements won across all practice areas, we have the experience and track record needed to secure maximum compensation for our clients.

We have filed Zantac lawsuits alleging the drug maker defendants have known for decades that the ranitidine molecule is capable of producing staggering amounts of the carcinogen NDMA when ingested as directed. Rather than warning people about the Zantac cancer risk, the drug makers willingly chose to put profit over people.

Our clients would never have purchased or used this drug had the manufacturers properly disclosed potentially fatal Zantac side effects. Outraged by the recklessness of these companies, we intend to hold them accountable for the damage they have caused.

Wisner Baum Zantac Attorneys Are in Active Litigation. If You Were Diagnosed with Cancer After Taking Zantac, You May be Eligible to Pursue Compensation in a Ranitidine Lawsuit. Contact Us Online or Call (855) 948-5098 to See if You Qualify.

Join the Zantac Cancer Lawsuit

Wisner Baum is one of the leading firms in the Zantac litigation. In practice for nearly 50 years, our firm has earned a reputation for winning big cases against big companies. One of our greatest successes in litigation shares similarities to the Zantac litigation. Our lawsuits against Monsanto (now part of Bayer) involved allegations that a consumer product causes cancer (non-Hodgkin’s lymphoma).

At trial, co-lead counsel R. Brent Wisner delivered the opening and closing statements before the jury. Wisner and his colleagues earned a $2.055 billion jury verdict* for our clients, one of the largest personal injury jury verdicts in U.S. history. A similar case resulted in a $289.2 million jury verdict* on behalf of our client, the second-largest jury verdict in the state of California for 2018.

Put your case in the hands of an experienced legal team that understands what it takes to earn the results clients deserve.

*Jury verdicts later reduced

Zantac Lawyer Appointed to Leadership Role in Litigation

Zantac lawyer R. Brent Wisner serves as Co-lead Plaintiffs’ Liaison Counsel for the Ranitidine Product Cases, also known as the Ranitidine (Zantac) Judicial Council Coordinated Proceedings (JCCP 5150) in California Superior Court for the County of Alameda. He will serve as co-lead counsel in the first Zantac trial, which is scheduled to begin on February 27, 2023.

In addition to his leadership position, Brent also serves as Co-Chair of the Zantac Litigation Group for American Association for Justice and has been invited to deliver numerous Zantac presentations at prestigious national lawyer conferences across the nation.

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Billions Won for Our Clients

  • Paxil Pediatric Class Action $63 Million
  • Third-Party Payer Class Action $40 Million
  • Defective Drug Class Action $28 Million
  • Celexa-Lexapro Pediatric Class Action $10 Million
  • Drug Injury $9 Million
  • Pharmaceutical Settlement $105 Million

Current Status of the Zantac Lawsuit

  • March 23, 2023 – Today, the Honorable Judge Evelio M. Grillo issued a 63-page order denying GSK’s effort to toss the case of James Goetz v. GlaxoSmithKline, LLC. Judge Grillo affirmed that 9 out of plaintiff’s 10 experts will be permitted to testify in open court.

    “We are pleased but not surprised that Judge Grillo has denied GSK’s bid to evade responsibility for the harm they have caused Mr. Goetz and countless others diagnosed with cancer after taking Zantac,” says Wisner Baum managing partner and senior trial attorney R. Brent Wisner. “As we approach the three-year anniversary of the FDA ordering the recall of Zantac for containing a known carcinogen, the California court order validates what we have been saying for years—that the evidence needs to be shown to a jury.

    “Our client will now have his day in court, and we look forward to sharing the evidence with the jury that GSK has known for decades that Zantac contains staggering amounts of a proven carcinogen,” said Jennifer A. Moore, co-lead trial counsel for Mr. Goetz.

  • March 2, 2023 – Sargon hearing in the case of James Goetz v. GlaxoSmithKline, LLC continues on March 2. We anticipate a ruling on expert testimony shortly after the conclusion of the Sargon hearing. As of this writing, there are no other Zantac cases scheduled for trial, so the Goetz case will be the first Zantac trial in the nation. Jury selection will begin in July.
    In addition to the California cases, our firm has more than 7,000 cases filed in Delaware State Court on behalf of plaintiffs in all 50 states, and we continue to file more cancer lawsuits each month. While there are no trial dates in Delaware, this is another growing venue for Zantac lawsuits.
  • February 23, 2023 – Jury selection in the first Zantac trial in California State Court is scheduled for July 24, 2023. Judge Evelio Grillo is currently considering what expert testimony will be allowed during trial in the case of James Goetz v. GlaxoSmithKline, LLC. Mr. Goetz alleges in his Zantac lawsuit that he developed bladder cancer after taking the drug. His case is the first “bellwether” case, an early test of how Zantac cancer lawsuits will fare in state courts.
  • February 16, 2023 – Today, Judge Grillo held a hearing on Sargon, which allows the legal teams for the plaintiffs and the defendants to present their expert witnesses and educate the court on the science that underpins their arguments. The hearing will continue on February 23 at 1:30 p.m. PST and will be livestreamed via CVN.

    After Sargon is completed, Judge Grillo will carefully consider the expert opinions and decide whether the experts used sound logic and valid methodologies to arrive at their scientific opinions. If Judge Grillo determines that the experts used valid methodologies, then Zantac cases in the JCCP can proceed to trial and the experts will be allowed to provide evidence and testimony on whether Zantac causes cancer, and whether that propensity for inducing cancer caused a particular Zantac user to develop cancer.

    If plaintiffs’ experts pass muster in Sargon, the first bellwether trial (Goetz v. GlaxoSmithKline, et al.) will begin. This will likely be the first Zantac trial in the country. Wisner Baum managing partner R. Brent Wisner will co-try the Goetz case with Jennifer Moore of the Moore Law Group.

    The trial was scheduled to begin on February 27, but because the Sargon hearing will not be completed until February 23 at the earliest, the trial date is not confirmed. We will issue another update on the trial date once we have more information.

  • December 6, 2022 – The federal judge overseeing the federal Zantac MDL in Florida issued an order that effectively dismissed all cases filed in federal court. While those in the plaintiff’s leadership have said they plan to appeal, this is not welcome news for claimants with cases in the MDL.

    At Wisner Baum, we want our clients to know that we do not have any cases filed in the MDL—all of our cases are filed in state courts. The order in the MDL does not directly affect our clients.

    “We had concerns about the MDL and felt like this was always a possible outcome,” says Wisner Baum Zantac lawyer, R. Brent Wisner. “That’s why we decided early on that the MDL was not the proper venue for our clients.” As for the state court cases and the upcoming Zantac trial in February of 2023, Wisner adds, “I am not too concerned with the MDL order because at the end of the day, the science is on our side. We have different experts and an unbiased judge. I have every confidence that our experts will pass muster, which means this case will be decided by a jury, as it should be. Once a jury hears the evidence, I don’t think they’ll be able to deny that Zantac can cause cancer.”

  • August 26, 2022 – A brief update on the number of Zantac lawsuit claims:
    • More than 2,000 people are suing over the Zantac cancer link in California, Delaware, Florida, Illinois, Nevada, New York, Pennsylvania, and Tennessee State Courts. Zantac cancer lawyers predict the number of claims could reach 50,000 by October.
    • As for the federal Zantac MDL in Florida, more than 1,700 claims have been filed. In September, the judge overseeing the federal cases will decide which expert testimony about the link between Zantac and cancer will be admissible at trial during Daubert hearings. The outcome of the Daubert hearings will determine whether the cases can go to trial.
  • August 18, 2022 – Just days before trial was scheduled to begin in Illinois state court, several generic ranitidine manufacturers announced Zantac settlement agreements with the plaintiff worth more than $500,000. The Illinois State Court case would have been the first Zantac trial in the country. The Zantac settlements with Teva Pharmaceutical Industries Ltd., Perrigo Co., Sun Pharmaceutical Industries Inc. and Dr. Reddy’s Laboratories Inc. were negotiated over the last few months.
  • August 12, 2022 – According to Bloomberg, growing concerns that juries may award significant Zantac payouts led to a massive selloff of Sanofi and GSK stocks. Investors pulled roughly $40 billion from Sanofi and GSK (including GSK consumer health affiliate Haleon) in just a couple of days. The Bloomberg piece added that one analyst estimated exposure for Sanofi, GSK, Pfizer, and Boehringer Ingelheim at as much as $45 billion.
  • Bloomberg interviewed Zantac cancer attorney R. Brent Wisner for the story. According to Wisner, “[w]e’ve had some really interesting discovery in the last six months showing that they knew about this problem and were negligent in the way they did things.”

  • June 22, 2022 - The California JCCP has made some important updates to the trial schedule in the Zantac litigation:
    • February 16, 2023: Court hearing on Sargon. This hearing gives the legal teams for the plaintiffs and the defendants the opportunity to present their experts and educate the court on the science that underpins their arguments.
    • February 27, 2023: The first Zantac bellwether trial in the California JCCP is scheduled to begin. This will likely be the first Zantac trial in the country.
    • May 1, 2023: The second Zantac bellwether trial in the California JCCP is scheduled to begin.
    • August 7, 2023: The third Zantac bellwether trial in the California JCCP is scheduled to begin.
    • October 23, 2023: The fourth Zantac bellwether trial in the California JCCP is scheduled to begin.
  • May 17, 2022 - The California JCCP held a Case Management Conference (CMC). With several motions on the calendar, oral argument took priority, and the CMC was continued. The next CMC is scheduled for late June where we anticipate some major updates.
  • December 15, 2021 – Zantac trial dates are tentatively scheduled in several state courts. The first bellwether case in California state court for the consolidated Ranitidine Product Cases JCCP 5150 is scheduled for October of 2022. The first trial in the federal Zantac cases consolidated in Re: Zantac (Ranitidine) Products Liability Litigation (Zantac MDL) will likely take place in mid-to-late 2023.
  • June 14, 2021 - Wisner Baum Named to Plaintiffs’ Leadership in Zantac JCCP – Plaintiffs can now pursue Zantac cancer claims in California state court as part of a newly established Judicial Council Coordinated Proceedings (JCCP). The Ranitidine Product Cases JCCP 5150 is the largest state court proceeding in the country for Zantac lawsuits. Zantac attorney R. Brent Wisner was appointed to the JCCP leadership as one of two Plaintiffs’ Liaisons.
  • June 8, 2020 - 40 Zantac Cancer Lawsuits Filed in California – This was our largest group of cases filed to date in California state court related to both generic ranitidine and brand name Zantac products. We filed lawsuits on behalf of 40 people with Zantac-induced cancer.
  • Oct 21, 2019 - Zantac Lawsuits Seek Punitive Damages Against Drug Makers – We filed our first Zantac cases in 2019 against multiple Zantac manufacturers, including Boehringer, Sanofi, Chattem, Pfizer and GSK alleging that they knew about the NDMA defect but failed to warn consumers about its link to cancer. The lawsuits also allege the companies defectively designed Zantac and deliberately refused to test Zantac products because they knew it put people’s health in serious danger.

To stay up to date on the latest updates in the Zantac MDL and the California Zantac JCCP, please visit the Zantac Trial Schedule page.

What Is Zantac?

Zantac is the brand name for ranitidine. Chemically known as ranitidine hydrochloride (or ranitidine Hcl), Zantac belongs to a class of drugs called histamine H2-receptor antagonists (or H2 blockers), which decrease the amount of acid produced by the stomach.

Common uses for Zantac include the treatment of acid reflux, heartburn, and a host of other stomach, throat, and gastrointestinal issues. Others use Zantac for allergies to supplement their treatment regimen.

Zantac dosage varies between 75 and 150 mg tablets, though some patients take a once daily Zantac 300 mg dosage. Some common Zantac and generic ranitidine products include:

  • Zantac 150 Tablets
  • Zantac 150 Maximum Strength
  • Zantac 150 Maximum Strength Cool Mint
  • Zantac 75 Tablets
  • Wal-Zan 150
  • Wal-Zan 75
  • Heartburn Relief (ranitidine)
  • Acid Reducer (ranitidine)
  • Acid Control (ranitidine)

Unsure if you took Zantac (ranitidine)? You can use this pill identification app or you can look through this series of Zantac and ranitidine pill images.

What is a Safe Zantac Replacement?

Deciding on a safe Zantac replacement is something you should discuss with your doctor. The FDA recommends the following Zantac alternatives:

  • Prilosec (omeprazole) – A proton pump inhibitor (PPI) medication commonly used to treat stomach acid-related conditions, including gastroesophageal reflux disease (GERD).
  • Nexium (esomeprazole) – A proton pump inhibitor (PPI) that reduces stomach acid production and treats GERD, ulcers, and other conditions.
  • Prevacid (lansoprazole) – A proton pump inhibitor (PPI) recommended for short-term ulcer and acid reflux treatment.
  • Pepcid (famotidine) – An H2 blocker that treats ulcers, GERD, and conditions that cause excess stomach acid.
  • Tagamet (cimetidine) – An H2 blocker that reduces acid in the stomach to treat ulcers and acid reflux.

History of Zantac (Ranitidine)

Drug maker GlaxoSmithKline (GSK) brought Zantac to market in 1983. Due in large part to GSK’s marketing strategy, which emphasized the drug’s purported safety, Zantac became a wildly successful drug, reaching $1 billion in total sales by the end of 1986.

Ten years later, Zantac became available without a prescription, and generic versions of Zantac (ranitidine) became available in 1997. Although sales of brand-name Zantac declined as a result of generic and alternative products, Zantac sales remained strong over decades. As recently as 2018, Zantac was one of the top 10 antacid tablet brands in the country, with sales of Zantac 150 totaling $128.9 million—a 3.1% increase from the previous year.

But since Zantac’s introduction, numerous studies have demonstrated a link between the NDMA in Zantac and certain types of cancer. Mounting evidence also allegedly shows that the defendant drug companies in our lawsuits concealed the Zantac cancer link from millions of people who took the drug for heartburn, gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), sour stomach, Barrett’s esophagus, acid reflux, and other issues. This deception came as the companies made unprecedented profits from Zantac.

“We have an epidemic of cancer in our society. For years we have been trying to figure out what’s behind it. Our firm has done a lot of work exposing the causes of non-Hodgkin lymphoma in our Monsanto Roundup litigation. Now we have another source of cancer – it appears that for decades, Zantac has been causing cancer, and we’re only now just seeing it. People from all across the country have cancer today because they took Zantac. That is a wrong that we will fight to make right.”

R. Brent Wisner

Zantac Lawsuit FAQs

  • Q:How Do You Qualify for a Zantac Lawsuit?

    A:The general criteria listed below for Zantac lawsuit eligibility is based predominantly on court orders and prevailing scientific research. Please note that Zantac case criteria can change at any time.

    Zantac Use for a Year or More Before Cancer Diagnosis 
    Potential Zantac claimants must have taken Zantac or generic ranitidine:
    - With some regularity;
    - Within 10 years of their cancer diagnosis;
    - For a period of at least 12 months.

    Eligible Zantac Cancer Types
    The courts have deemed the following cancer types as eligible for Zantac lawsuits (subject to change):
    - Bladder cancer
    - Esophageal cancer
    - Liver cancer
    - Pancreatic cancer
    - Stomach cancer

  • Q:My Cancer is Not Listed…Do I Have a Zantac Case?

    A:At this time, our law firm is unable to pursue cases on behalf of individuals who do not meet the general criteria listed above. Please understand that this does not mean that you are ineligible to pursue a case or that your injuries are not substantial enough. It simply means that we do not believe that we would be able to successfully pursue a claim on your behalf.

  • Q:Is My Zantac Lawsuit Part of a Class Action?

    A:It depends on your claims for damages. For example, if you took Zantac and were diagnosed with some form of cancer (or if a family member took Zantac and was diagnosed with cancer), you may be eligible to file a personal injury lawsuit against the manufacturers of Zantac and/or over-the-counter Zantac (OTC). An individual personal injury Zantac lawsuit allows people who developed cancer to obtain the maximum possible compensation for their injuries. Conversely, if you took Zantac and never developed cancer, you could still seek compensation by filing a class action lawsuit against the makers of prescription Zantac and/or Zantac OTC. A Zantac class action lawsuit allows consumers who purchased prescription Zantac or generic Zantac (ranitidine) to recover the money spent on purchasing the medication.

  • Q:Who Can Join the Zantac Class Action Lawsuit?

    A:Anyone who purchased Zantac and can prove they did so may be eligible to participate in a Zantac class action claim. Unlike individual lawsuits against Zantac’s makers, in a class action lawsuit, plaintiffs do not have to prove that they were harmed, only that that they purchased the drug and were not warned about the Zantac cancer risk. Such plaintiffs argue that they suffered economic losses because they purchased the drug believing it was safe and would not have made that purchase had they known about the risk of life-threatening Zantac adverse effects.

  • Q:How Much Can I Get From Zantac Lawsuit?

    A:Most of the people who contact our legal team want to know how much their Zantac case is worth. The truth is, we can’t give them a good answer because each case is different. What we can say is that the Zantac litigation will likely end in settlement agreements where cases are ranked using a tier system based on severity of injuries and strength of claim. 

  • Q:What Will It Cost to Hire a Zantac Attorney?

    A:We provide free Zantac case reviews to anyone who fills out our contact form or calls our offices. It costs you nothing out of pocket to retain our law firm to represent you and pursue justice and compensation on your behalf. We don’t see a dime until we win your case.

  • Q:Should I Hire a Zantac Lawyer Near Me?

    A:Many people have an instinct to hire a local attorney to handle their case. In a nationwide mass tort litigation like Zantac, your lawyer’s location is not as important as their experience and track record in successfully resolving cases similar to yours.

    Here’s what you should be looking for in a Zantac lawyer:
    - Proven track record in similar cases
    - Resources needed to take on major corporate defendants
    - Trial-ready litigation team that prepares cases to go before juries to maximize your compensation
    - Compassionate, friendly representation that puts your needs first
    - Availability if an when you have questions about your claim

  • Q:Where are Zantac Cases Filed?

    A:Zantac lawsuit cases have been filed in federal court or in state courts. At the start of the litigation, the federal cases were consolidated in the Zantac multidistrict litigation (Zantac MDL) before U.S. District Court Judge Robin L. Rosenberg for the Southern District of Florida. However, Judge Rosenberg issued an order granting Zantac defendants’ motion for summary judgment, which effectively dismissed all the federal cases. They are appealing that decision, and rightfully so, but until those dismissals are resolved, the case is effectively over in the federal system. Early on, however, we specifically thought to file our cases in state court—indeed, we formed a consolidated proceeding in California, and we will be going to trial in February 2023. This means that the state courts will be the primary venues for Zantac cases moving forward. The primary state courts with Zantac cases include:

    - California
    - Delaware Illinois
    - Illinois

Is your law firm looking to refer Zantac cases? Please visit our Zantac Case Referral page for more information.

Why Was Zantac Taken Off the Market?

Zantac (ranitidine) was taken off the market because the drug contains unacceptable levels of N-Nitrosodimethylamine (NDMA), which is a substance known to cause cancer. Testing of ranitidine drugs showed levels of NDMA above the FDA’s acceptable daily intake limit of 96 nanograms (ng) per day. For example, testing from Connecticut-based online pharmacy Valisure detected NDMA in excess of 3,000,000 ng per tablet when analyzing ranitidine products.

Valisure tests medications for consistency and quality issues. During testing, the company discovered extremely high levels of NDMA “in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.”

Valisure’s finding was consistent with studies from Stanford University and elsewhere, which found that NDMA in Zantac was likely due to the “inherent instability” of the ranitidine molecule.

“There’s no acceptable cancer risk for a drug like this,” said David Light, CEO of Valisure.

Valisure reported its findings to the FDA in June of 2019. Three months later, the company filed a citizen’s petition urging the FDA to issue a Zantac recall and suspend all sales:

“Combined with other data from Valisure and the scientific works of Stanford University and others, the evidence presented shows this instability and the resulting NDMA occurs in the conditions representative of those in the human body and builds a compelling case for ranitidine being a likely human carcinogen.”

On Jan. 2, 2020, research laboratory Emery Pharma filed a citizen’s petition of its own noting that ranitidine is a time and temperature-sensitive pharmaceutical product that develops into NDMA when exposed to heat. In a press release, Emery Pharma noted:

“Exposure to high temperatures is a common occurrence during transportation and storage, and is of specific concern to ranitidine as there currently are no requirements for the drug to be shipped in temperature-controlled conditions and/or stored under refrigeration.”

Ranitidine is a very unstable molecule. On one side, you have the N (Nitroso). On the other side, you have the DMA (Dimethylamine). When the molecule is exposed to heat, various biological processes in the stomach, and enzymatic reactions throughout the body, it shears apart and reconstitutes as NDMA. But the formation of NDMA is not limited to the reaction in human stomach. Ranitidine can turn into NDMA in the pill bottle itself. In fact, our Zantac lawsuits allege that the drug manufacturers for decades had this problem where ranitidine turned yellow in storage. If it’s yellow, that’s NDMA. They claim they had no idea why this was the case, but our lawsuits say otherwise—they knew.” Zantac Attorney R. Brent Wisner

What is NDMA in Zantac?

N-Nitrosodimethylamine (NDMA) is a water-soluble organic (containing the element carbon) chemical and appears as a yellow liquid with little or no obvious taste or odor. NDMA was once used to make rocket fuel, but today is made only for research purposes. It can also be produced as a byproduct of manufacturing processes. Humans can be exposed to NDMA in relatively small amounts through various products, including tobacco, foods (cured meat, fish, cheese, beer), shampoos, cleansers, and pesticides.

NDMA is carcinogenic even in minimal doses. The FDA’s acceptable daily intake of NDMA is 96 nanograms (ng), or 96 billionths of a gram. Studies show that NDMA exposure as little as 179 ng per 100 grams per day is associated with elevated cancer risks.

The International Agency for Cancer Research (IARC), the most recognized cancer research institution in the world, studied over 200 research papers on NDMA and the NDMA cancer risk. IARC placed the chemical in the “Group 2A” category, meaning substances that are “probably carcinogenic to humans.” The agency found that NDMA is “carcinogenic in all animal species tested” and noted that the metabolism of NDMA by humans and animals is similar.

NDMA caused malignant tumor growth in several organs, in multiple species, via numerous routes of exposure (oral, inhalation, subcutaneous (under the skin), injections), with dose-response relationships appearing in several studies. Scientists are also gaining detailed knowledge of the body's biochemical mechanisms to repair NDMA DNA damage and how those mechanisms play a role in the progression towards cancer.

The FDA, Environmental Protection Agency (EPA), and World Health Organization (WHO) all classify as a substance capable of causing cancer.

Zantac Recall Update

The following companies issued voluntary Zantac recall announcements, citing safety concerns:

  • American Health Packaging
  • Amneal Pharmaceuticals
  • Aurobindo Pharma USA
  • Apotex Corp. (this includes over-the-counter ranitidine tablets 75 mg and 150 mg, labeled by Walgreens, Walmart, and Rite-Aid)
  • Appco Pharma
  • Denton Pharma (dba Northwind Pharmaceuticals)
  • Reddy’s Laboratories (this includes Zantac over-the-counter OTC medicines labeled by retailers such as Walgreens, Walmart, CVS, Target, and Kroger)
  • GlaxoSmithKline (GSK)
  • Glenmark Pharmaceuticals
  • Golden State Medical Supply
  • Lannett Company
  • Novitium Pharma
  • Perrigo Company
  • Precision Dose
  • Sandoz
  • Sanofi

On April 1, 2020, the FDA issued a market withdrawal request of all Zantac (ranitidine) products, effective immediately. The FDA announcement noted that agency studies on Zantac showed “risk to public health.” As such, the agency said ranitidine products “will not be available for new or existing prescriptions or OTC use in the U.S.”

To stay updated on Zantac (ranitidine) recall announcements, we advise you to consult the FDA’s Recalls, Market Withdrawals, & Safety Alerts page. The FDA alerts consumers with the recall reason and lists Zantac recall lot numbers, if applicable.

Did the FDA Issue a Zantac Recall in 2019?

Despite evidence that Zantac can cause cancer, the U.S. Food and Drug Administration (FDA) did not immediately issue a Zantac recall in 2019. The agency warned consumers that testing of the popular heartburn medication Zantac (generic ranitidine) revealed a known cancer-causing chemical, N-nitrosodimethylamine (NDMA) at more than 3,000 times the legal daily intake limit.

While the FDA was reluctant to issue a Zantac recall in 2019, retail outlets like Walgreens, Walmart, Rite Aid, CVS and others pulled the popular medication from shelves. Generic drug makers like Sandoz (a division of Novartis), GSK, and Apotex also issued generic Zantac recalls in 2019; and nearly two dozen countries stopped or restricted sales of the popular medication.

The FDA issued a market withdrawal for Zantac in 2020. A market withdrawal is different than a recall. Per the FDA, here is the difference between a recall and a market withdrawal:

Market withdrawal: Involves a minor violation that would not be subject to legal action by the FDA.

Recall: The correction or removal of a marketed product that the FDA considers to be in violation of the laws it administers.

2018 NDMA Recall

In 2018, some companies issued recalls after the discovery of high levels of NDMA in multiple generic forms of the blood pressure drug valsartan. The levels of NDMA in these products, however, paled in comparison to that of Zantac.

The 2018 recalls were reportedly linked to NDMA that formed during manufacturing after active ingredient suppliers in India and China sold components of the medication to generic drug makers. Government officials have not commented on how NDMA ended up in the drugs.

Zantac Lawyers Call for FDA Ranitidine Recall

The Zantac cancer lawyers at Wisner Baum believe the FDA’s decision to issue a market withdrawal for Zantac is a necessary step toward protecting people from a dangerous drug. However, more can and should be done. Our firm has been calling for a Zantac recall since the summer of 2019 because there is no level of NDMA that is safe.

Zantac 360 with Famotidine on the Market Following Ranitidine Recall

In response to the Zantac recall announcements and the FDA’s market withdrawal for ranitidine, Sanofi announced a new Zantac product in 2021 called Zantac 360. Zantac 360 is made with famotidine as the active ingredient instead of ranitidine. With two different active ingredients, Zantac 360 is not the same as the original Zantac.

Many people may recognize famotidine, as it is the same active ingredient used in another popular OTC heartburn drug, Pepcid AC. While both famotidine and ranitidine are in the same class of drugs (H2 blockers), famotidine is considered a safe ranitidine replacement because it does not contain NDMA at high levels.

Does Zantac Cause Cancer?

Yes, Zantac can cause cancer. The ranitidine molecule produces high levels of N-Nitrosodimethylamine (NDMA) when the drug is used as directed. The U.S. Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the World Health Organization (WHO) classify NDMA as a cancer-causing chemical. The ranitidine molecule contains both a nitrite and a dimethylamine (DMA) group. These combine to form NDMA.

Numerous studies have found that the NDMA in Zantac causes bladder cancer, stomach cancer, pancreatic cancer, and other forms of cancer. Below we highlight some of the most important research on Zantac.

2019 Valisure Study: How Zantac (Ranitidine) Produces NDMA

In 2019, Valisure conducted batch testing for Zantac (ranitidine) using FDA-recommended protocols. Valisure found NDMA levels as high as 3,267,968 ng (nanograms) per Zantac tablet, more than 34,000 times higher than the FDA limit of 96 ng or .096 mcg (micrograms).

Wondering if the increased heat of the testing process may have contributed to these results, Valisure decided to test ranitidine under conditions that simulated those found in the stomach (simulated gastric fluid with sodium nitrite). NDMA levels, while not as high, were still extraordinary, ranging from 23,600 ng to 304,500 ng, over 3,100 times the FDA’s “safe” limit.

“Valisure’s testing reveals NDMA levels so high that the nitroso for NDMA likely comes from no other source than the ranitidine molecule itself.” [Nitroso refers to an atomic grouping of nitrogen and oxygen, such as found in the nitrite group of NDMA.]

Valisure Citizen Petition on Ranitidine, September 9, 2019

Valisure also points to a third mechanism that could lead to NDMA production after Zantac is ingested – an enzyme, dimethylarginine dimethylaminohydrolase (DDAH), that can react with ranitidine to “liberate” DMA from ranitidine, making it available to combine with nitrite from the ranitidine molecule, nitrite circulating in the body, or “other potential pathways particularly in weak acidic conditions such as that in the kidney or bladder.” This mechanism, according to Valisure, could generate millions of nanograms of NDMA throughout the body.

2021 Valisure Study on Zantac (Ranitidine)

The 2021 Valisure Zantac study analyzed NDMA production “under simulated physiologic gastric states.” What does this mean exactly? Researchers conducted the study by mimicking the human stomach ingesting a Zantac tablet across a broad range of pH concentrations, ranitidine concentrations, and nitrite concentrations. The study used FDA-recommended protocols for determining nitrosamines in ranitidine tablets.

The study found that Zantac “may be a significant source of NDMA under a range of physiologically relevant conditions.” Under numerous conditions meant to simulate the human stomach, Zantac NDMA levels increased with increasing nitrite levels and decreasing pH levels up to three orders of magnitude beyond established limits. The authors cautioned, “these data support recent regulatory actions to limit ranitidine availability.”

Study on Zantac Published in Cancers

Cancers published a study on Zantac in December of 2020. Researchers looked at data from the FDA’s Adverse Events Reporting System (FAERS), searching adverse event reports of cancer stemming from primary and secondary use of proton pump inhibitors (PPIs) and H2 antagonists, the group of drugs to which Zantac belongs.

The study found elevated incidences of esophageal cancer, pharyngeal cancer, liver cancer, and pancreatic cancer, and stomach cancer, among others. The Cancers study provides “support for the assertion that NDMA contaminated ranitidine is associated with the occurrence of gastrointestinal cancer. This assertion was bolstered by an abundance of evidence demonstrating that NDMA exposure is associated with an increased risk of cancer in humans as well as animals.”

This research is similar to data from a 2000 study, which investigated the association between prescription ranitidine use and specific cancers. In the 2000 study, researchers found a statistically significant 2.4-fold increased risk for stomach cancer and esophageal cancer.

Sloan Kettering Study Finds Association Between Ranitidine and Cancer

Researchers from the Sloan Kettering Cancer Center conducted the study, ‘Ranitidine use, N-Nitrosodimethylamine (NDMA) production and variations in cancer diagnoses’. The study used similar methods to the 2021 Valisure study above.

The Sloan Kettering study analyzed ranitidine NDMA production under various simulated gastric conditions. Researchers also conducted an epidemiologic analysis to evaluate potential associations between ranitidine and several forms of cancer.

According to the authors, Zantac produces increasing amounts of NDMA over time (up to, and likely beyond four hours) and with increasing sodium nitrite concentrations. The study found positive associations for several cancers, including bladder cancer.

Epidemiological Studies of Zantac and Cancer

Very few epidemiological studies of patients taking Zantac have been conducted. In a study conducted by the National Cancer Institute, adult male health professionals with peptic ulcers were followed for 14 years (1986 – 2000). The subjects of the study were asked if they used either Tagamet or Zantac as a treatment. The authors of the study reported that use of either drug was associated with an increased risk of bladder cancer, though the increase fell short of statistical significance.

Other Zantac Studies

A true Zantac cancer study in humans—where humans are deliberately given Zantac to ingest to observe the results—has not been conducted and never will, as it would be unethical. However, a 1983 study of ranitidine in rodents found that it produced several “genotoxic effects,” including DNA fragmentation in the liver and gastric mucosa (the mucous membrane that lines the stomach). Significantly, studies of Tagamet (cimetidine), another antacid in Zantac’s class (H2 blockers), did not show DNA damage.

Genetic damage is known to be at the root of all cancers. A 2013 meta-analysis of studies that examined the relationship between various acid-suppressing drugs and gastric cancer concluded that that “acid suppressive drugs are associated with an increased risk of gastric cancer.”

These studies support three important points underlying the danger posed by Zantac:

  • NDMA is carcinogenic in humans in exceedingly small amounts.
  • Levels of NDMA produced by Zantac are extremely high.
  • The problem with Zantac is not an “impurity” in the drug, but rather the design of the drug itself and how that design makes Zantac itself a carcinogen.

NDMA has not been directly tested in humans. The cancer risk is too high. However, we know from years of research that humans are regularly exposed to NDMA via many foods and beverages. This has provided a means of testing NDMA’s carcinogenic potential—and by extension the carcinogenicity of Zantac—in humans indirectly.

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